The EPigenetic Consequences in Children of Intravenous vs Volatile Anaesthesia for Surgery (EPIVA)

Summary

More than half a million children have an anaesthetic each year in the UK. Though anaesthesia is usually thought to be safe and necessary to improve health, concerns remain the effects that the drugs used may have on brain development in children and the potential long-term consequences for health. The two techniques used to keep someone asleep during anaesthesia are either giving the appropriate drugs through a small plastic tube into a vein or introducing different drugs into the lungs in gas form.

Gene expression is the process by which instructions in DNA are used to make products such as proteins. Anaesthetic drugs may change how a child's genes are expressed; a process called epigenetics. Studies have shown that different anaesthetic drugs can cause epigenetic changes in animals and affect the processing ability of their brains.

This study will focus on children aged under 3 undergoing general anaesthesia for planned hypospadias surgery (a developmental condition where the look and function of the penis may not be completely normally). Participants will either receive their general anaesthetic in gas form or through directly into their veins - both techniques are commonly used. A small blood sample (between 1 and 2 teaspoons) will be collected at the start and end of the operation whilst under anaesthetic. Samples will be analysed to look for any changes in signals on DNA (epigenetic changes) and other markers. Further analysis may then look at other measures of gene expression and additional processes/markers that could be affected.

There is relatively less medical research carried out in children and this work will show whether this type of study is possible in this age-group and provide information for future trials. It will help towards improving our understanding of the effects of anaesthesia ultimately help doctors and families make better informed decisions.

Conditions

• Hypospadias
• Anesthesia; Adverse Effect
• Perioperative Complication
• Pediatric ALL

Interventions

OTHER

Intravenous approach to anaesthetic maintenance

Anaesthetic agents given directly into the bloodstream via a cannula.

OTHER

Inhalational approach to anaesthetic maintenance

Volatile-based anaesthetic drugs are breathed in and then absorbed into the bloodstream through the lungs.

Sponsors & Collaborators

• University of Southampton

  collaborator OTHER

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Principal Investigators

• Joseph Larvin, BMBCH · University Hospital Southampton and University of Southampton

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

3 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-03

Primary Completion

2024-02-23

Completion

2026-09-30

Countries

• United Kingdom

Study Locations